Background: Trastuzumab is a blockbuster monoclonal antibody that has revolutionized the treatment of HER2-positive breast and gastric cancers. With the increasing availability of biosimilar monoclonal antibodies in clinical practice, independent verification of biosimilarity using products sampled from a real-world supply chain is important to assure clinicians and the patients to use these products confidently. Objective: The aim of this study is to assess the biosimilarity of AryoTrust, a trastuzumab biosimilar, in comparison with the reference product Herceptin. AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings. Methods: AryoTrust and Herceptin were compared using an extensive set of orthogonal analytical techniques which included SDS-PAGE, ion-exchange chromatography, capillary isoelectric focusing, peptide mapping, N-glycan profiling, circular dichroism, differential scanning calorimetry, and surface plasmon resonance. In addition to these teste, functional comparability was also tested using an HER2-dependent cell-based proliferation inhibition bioassay. Results: The results showed that both products have highly comparable profiles in all assessed attributes. The analysis showed similar molecular integrity and purity, identical primary structure, comparable charge heterogeneity, similar isoelectric points (pI) of the main isoform, close glycosylation patterns (mainly, by core-fucosylated complex-type glycans), similar higher-order structural features, and thermal stability. The receptor binding studies exhibited comparable binding affinities with Fcγ receptors and FcRn. Finally, the cell-based bioassay revealed comparable dose–response curves with similar EC50 values and relative potency. Conclusions: The integrated analytical and functional data support the biosimilarity of AryoTrust to the reference product Herceptin, which has been marketed and used in Iraq. This study provides real-world scientific evidence supporting confidence in the quality and comparability of this trastuzumab biosimilar and reduces any doubt in the product and at the same time emphasizes the value of independent post-marketing biosimilarity assessments.
Abstract
This research deals will the declared production planning operation in the general company of planting oils, which have great role in production operations management who had built mathematical model for correct non-linear programming according to discounting operation during raw materials or half-made materials purchasing operation which concentration of six main products by company but discount included just three products of raw materials, and there were six months taken from the 1st half of 2014 as a planning period has been chosen . Simulated annealing algorithm application on non-linear model which been more difficulty than possible solution when imposed restric
... Show MoreThe planning for the formation of administrative policies and guidance through leadership are important things for managing administrative processes and sporting activities. As both contribute in the stability of the administrative conditions, and their development in the sport federations, whether they both were attentive about team and individual Olympic Games. The two researchers observe that, there is a variation in the correct way of application. Particularly in the formulation of administrative policies and leadership describing it as, modern management standards for both team and individual Olympic Games in the Iraqi National Olympic Committee. That led to cause a misconception and lack of clarity for some administrators of those uni
... Show MoreThe aim of this paper to study the effect of the implicit factors on the entrepreneurial spirit of the students of the Algerian university. Our structural model was proposed based on the model (Shapiro et Sokol, 1982) and the model (Ajzen, 1991). We tested it on a sample of 163 university students at the University of Algiers 3. The model consists of a set of variables (the intention of contracting as a dependent variable, structural and social educational support as independent variables). The results showed that educational and social support factors affect the entrepreneurial spirit of students more than structural support. The Applied Impacts are the enhancing of knowledge capacities of university stu
... Show MoreThe importance of news broadcasts in society has increased after the domination of television over the mass media, especially after emerging the satellite channels, and spreading the satellite dishes among the public at large.
As well as the great role played by the modern technology in the transmission of news and events happening at once. Such role has contributed, significantly, in changing the concept and values of the news. The live broadcast of the events filmed is the news itself.
In the midst of the great transformations and circumstances that Iraq went through after 2003, which witnessed political and security instability, and the large increase in the number of media, especially satellite channels, in Iraq
... Show MoreThe study was conducted in the poultry field, College of Agriculture, Al-Muthanna University from 1/3/2018 to 6/4/2018 to determine the effect of commercial Ascomax powder produced from seaweed (Ascophyllum nodocum) on some productive performance of broilers. A total of 400, one day, Ross 308 broiler chicks were used for 35 days. The chicks were randomly distributed to 4 treatments, four replicates per treatment (25 chick / replicate). The treatments were as follows: T1: (control treatment), while T2, T3 and T4 added diet by Ascomax powder by 1, 1.5 and 2 g per 1 kg of the basal diet, respectively. The results of the study showed a significant superiority (P <0.05) for the added Ascomax powder treatments compared to the treatment of control
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due to the presence of chemoresistance and the risk of tumor recurrence and metastasis. There is a pressing necessity to develop efficient treatments to improve response for treatment and increase prolong survival of breast cancer patients. Photodynamic therapy (PDT) has attracted interest for its features as a noninvasive and relatively selective cancer treatment. This method relies on light-activated photosensitizers that, upon absorbing light, generate reactive oxygen species (ROS) with powerful cell-killing outcomes. Nuclear factor kappa B (NF-κB), a transcription factor, plays a key role in cancer development by regulating cell proliferation, differentiation, and survival. Inhibiting NF-κB can sensitize tumor cells to chemotherapeuti
... Show MoreThe aim of organizational contemporary is development man power active, in spit-of there are littlie resources. But in the Iraqi environment there are too much resources with performance inhabiting. specially in the ministry of water resources (sample of this research), about dryness and lower levels of rivers. There for this study have some important variable, it is ethical leadership & transformational leadership as (independent variable), and Perceived organizational support(dependent variable). Over here to invest with authority on the problem of research, is weakness harmony between employed perception and the pattern of leadership. We find decline in of reaction of organ compound between the variable to weaken high perf
... Show MoreCost is the essence of any production process for it is one of the requirements for the continuity of activities so as to increase the profitability of the economic unit and to support the competitive situation in the market. Therefore, there should be an overall control to reduce the cost without compromising the product quality; to achieve this, the management should have detailed credible and reliable information about the cost to be measured, collected, understood and to analyze the causes for the spread of deviations and obstacles the management faces, and to search for the factors that trigger the emergence of these deviations and obstacles